Glossary

A type of
eligibility criteria that indicates whether people who do not have the
condition/disease being studied can participate in that clinical study.

An
arm type in which a group of participants receives an
intervention/treatment considered to be effective (or active) by health care providers.

An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. This change may or may not be caused by the
intervention/treatment being studied.

A type of
eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups:

The age groups are:

Child (birth-17)

Adult (18-64)

Older Adult (65+)

A method used to assign participants to an arm of a clinical study. The types of allocation are
randomized allocation and nonrandomized.

A group or subgroup of participants in a clinical trial that receives a specific
intervention/treatment, or no intervention, according to the trial's
protocol.

A general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include
experimental arm,
active comparator arm,
placebo comparator arm,
sham comparator arm, and
no intervention arm.

Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, prior antidepressant treatment).

Indicates that the study sponsor or investigator recalled a submission of
study results before
quality control (QC) review took place. If the submission was canceled on or after May 8, 2018, the date is shown. After submission of study results, a
study record cannot be modified until QC review is completed, unless the submission is canceled.

Information required by the
Food and Drug Administration Amendments Act of 2007. In general, this is a description of any agreement between the sponsor of a clinical study and the
principal investigator (PI) that does not allow the PI to discuss the results of the study or publish the study results in a scientific or academic journal after the study is completed.

A sponsor or investigator may submit a certification to delay submission of results information if they are applying for FDA approval of a new drug or device, or new use of an already approved drug or device. A sponsor or investigator who submits a certification can delay results submission up to 2 years after the
certification/extension first submitted date, unless certain events occur sooner. See
Delay Results Type in the Results Data Element definitions for more information about this certification.

The date on which information about a
certification to delay submission of results or an
extension request was first available on ClinicalTrials.gov. ClinicalTrials.gov does not indicate whether the submission was a certification or extension request. There is typically a delay between the date the study sponsor or investigator submitted the certification or extension request and the
first posted date.

The date on which the study sponsor or investigator first submitted a
certification or an
extension request to delay submission of results. A sponsor or investigator who submits a certification can delay results submission up to 2 years after this date, unless certain events occur sooner. There is typically a delay between the date the certification or extension request was submitted and the date the information is first available on ClinicalTrials.gov (
certification/extension first posted).

The date on which the study sponsor or investigator first submitted a
certificationBag Cleo LeSportsac Crossbody Summer Fruits z08nOq4 or an
extension request that is consistent with National Library of Medicine (NLM)
quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a certification or extension request one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria. Meeting QC criteria for an extension request does not mean that the National Institutes of Health (NIH) has determined that the request demonstrates good cause. The process for review and granting of extension requests by the NIH is being developed.

In the search feature, the City field is used to find clinical studies with locations in a specific city. The Distance field is used to find studies with locations within the specified distance from a city in number of miles. For example, if you choose Illinois as the
state, identifying "Chicago" as the city and "100 miles" as the distance will find all studies listing a location within 100 miles of Chicago.

A research study involving human volunteers (also called participants) that is intended to add to medical knowledge. There are two types of clinical studies:
interventional studies (also called clinical trials) and
observational studies.

The unique identification code given to each clinical study upon
registration at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419).

An organization other than the
sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

In the search feature, the Country field is used to find clinical studies with locations in a specific country. For example, if you choose the United States, you can then narrow your search by selecting a
state and identifying a
city and distance.

A type of
intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. For example, two-by-two cross-over assignment involves two groups of participants. One group receives drug A during the initial phase of the trial, followed by drug B during a later phase. The other group receives drug B during the initial phase, followed by drug A. So during the trial, participants "cross over" to the other drug. All participants receive drug A and drug B at some point during the trial but in a different order, depending on the group to which they are assigned.

A group of independent scientists who monitor the safety and scientific integrity of a
clinical trial. The DMC can recommend to the sponsor that the trial be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose. Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

A
phase of research used to describe exploratory trials conducted before traditional
phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies).

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both
inclusion criteria (which are required for a person to participate in the study) and
exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study
accepts healthy volunteers, has
age or age group requirements, or is limited by
sex.

The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.

A type of
eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study.

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the
U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different
expanded access types.

Available:Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.

No longer available:Expanded access was available for this intervention previously but is not currently available and will not be available in the future.

Temporarily not available:Expanded access is not currently available for this intervention but is expected to be available in the future.

Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.

Describes the category of
expanded access under
U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:

Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.

Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.

An
arm type in which a group of participants receives the
intervention/treatment that is the focus of the clinical trial.

In certain circumstances, a sponsor or investigator may request an extension to delay the standard results submission deadline (generally one year after the
primary completion date). The request for an extension must demonstrate good cause (for example, the need to preserve the scientific integrity of an ongoing
masked trial). All requests must be reviewed and granted by the National Institutes of Health. This process for review and granting of extension requests is being developed. See
Delay Results Type in the Results Data Element definitions for more information.

A type of
intervention model describing a clinical trial in which groups of participants receive one of several combinations of interventions. For example, two-by-two factorial assignment involves four groups of participants. Each group receives one of the following pairs of interventions: (1) drug A and drug B, (2) drug A and a placebo, (3) a placebo and drug B, or (4) a placebo and a placebo. So during the trial, all possible combinations of the two drugs (A and B) and the placebos are given to different groups of participants.

The date on which the
study record was first available on ClinicalTrials.gov. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.

The date on which the study sponsor or investigator first submitted a
study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the
first posted date).

The date on which the study sponsor or investigator first submits a
study record that is consistent with National Library of Medicine (NLM)
quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.

U.S. Public Law 110-85, which was enacted on September 27, 2007. Section 801 of FDAAA amends Section 402 of the U.S. Public Health Service Act to expand ClinicalTrials.gov and create a clinical study
results database. For more information on FDAAA 801, see the
History, Policies, and Laws page on this site.

Describes the organization that provides funding or support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting. Organizations listed as
sponsors and
collaborators for a study are considered the funders of the study. ClinicalTrials.gov refers to four types of funders:

U.S. National Institutes of Health

Other U.S. Federal agencies (for example, Food and Drug Administration, Centers for Disease Control and Prevention, or U.S. Department of Veterans Affairs)

A type of
eligibility criteria that indicates whether eligibility to participate in a clinical study is based a person's self-representation of gender identity or gender (yes, no). Gender is distinct from
sex.

A group or subgroup of participants in an
observational study that is assessed for biomedical or health outcomes.

A group of people who review, approve, and monitor the clinical study's
protocol. Their role is to protect the rights and welfare of people participating in a study (referred to as human research subjects), such as reviewing the
informed consent form. The group typically includes people with varying backgrounds, including a community member, to make sure that research activities conducted by an organization are completely and adequately reviewed. Also called an institutional review board, or IRB, or an ethics committee.

The general design of the strategy for assigning interventions to participants in a clinical study. Types of intervention models include:
single group assignment,
parallel assignment,
cross-over assignment, and
factorial assignment.

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

A type of
clinical study in which participants are assigned to groups that receive one or more
intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's
protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study
principal investigator.

The most recent date on which changes to a
study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the
last update submitted date) and the last update posted date.

The most recent date on which the study sponsor or investigator submitted changes to a
study record to ClinicalTrials.gov. There is typically a delay of a few days between the last update submitted date and when the date changes are posted on ClinicalTrials.gov (the
last update posted date).

The most recent date on which the study sponsor or investigator submitted changes to a
study record that are consistent with National Library of Medicine (NLM)
quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a
Women Shopping Tote FancyPrint C8wca4955al Handbags Top Satchel Bages Handle recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's
recruitment status is shown as
unknown.

Countries in which research facilities for a study are located. A country is listed only once, even if there is more than one facility in the country. The list includes all countries as of the
Handbags Satchel Shopping Top FancyPrint Women Handle C8wca4955al Tote Bages last update submitted date; any country for which all facilities were removed from the
study record are listed under
removed location countries.

In the search feature, the Location terms field is used to narrow a search by location-related terms other than Country, State, and City or distance. For example, you may enter a specific facility name (such as National Institutes of Health Clinical Center) or a part of a facility name (such as Veteran for studies listing Veterans Hospital or Veteran Affairs in the facility name). Note: Not all
study records include this level of detail about locations.

A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which participants have been assigned which interventions. Types of masking include: open label, single blind masking, and double-blind masking.

A unique identification code given to each clinical study record registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the
ClinicalTrials.gov identifier.

An
arm type in which a group of participants does not receive any
intervention/treatment during the clinical trial.

A type of
clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific
FancyPrint Shopping Satchel Handbags Tote Handle Women Bages Top C8wca4955al interventions/treatment.

The general design of the strategy for identifying and following up with participants during an
observational study. Types of observational study models include cohort, case-control, case-only, case-cross-over, ecologic or community studies, family-based, and other.

An
adverse event that is not a
serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect; it also does not put the participant in danger and does not require medical or surgical intervention to prevent one of the results listed above.

Identifiers or ID numbers other than the
NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.

In the search feature, the Other terms field is used to narrow a search. For example, you may enter the name of a drug or the NCT number of a clinical study to limit the search to
study records that contain these words.

For
clinical trials, a planned measurement described in the protocol that is used to determine the effect of an
intervention/treatment on participants. For
observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include
primary outcome measure and
secondary outcome measure.

A type of
intervention model describing a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel assignment involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A "in parallel" to participants in the other group, who receive drug B.

A summary of the progress of participants through each stage of a clinical study, by study
arm or
group/cohort. This includes the number of participants who started, completed, and dropped out of the study.

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the
U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases:
Early Phase 1 (formerly listed as Phase 0),
Phase 1,
Phase 2,
Phase 3, and
Phase 4.
Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.

A
phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and
serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants.

A
phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain
condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a
placebo) or a different drug. Safety continues to be evaluated, and short-term
adverse events are studied.

A
phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

A
phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.

Describes trials without FDA-defined
phases, including trials of devices or behavioral interventions.

An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or
intervention/treatment being studied.

An
arm type in which a group of participants receives a
placebo during a clinical trial.

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the
primary outcome measure. Whether the clinical study ended according to the
protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.

In a clinical study's
protocol, the planned outcome measure that is the most important for evaluating the effect of an
intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.

The person who is responsible for the scientific and technical direction of the entire clinical study.

The written description of a clinical study. It includes the study's objectives, design, and methods. It may also include relevant scientific background and statistical information.

National Library of Medicine (NLM) staff perform a limited review of submitted
study records for apparent errors, deficiencies, or inconsistencies. NLM staff identify potential major and advisory issues and provide comments directly to the study sponsor or investigator. Major issues identified in QC review must be addressed or corrected (see
First submitted that met QC criteria and
Results first submitted that met QC criteria). Advisory issues are suggestions to help improve the clarity of the record. NLM staff do not verify the scientific validity or relevance of the submitted information. The study sponsor or investigator is responsible for ensuring that the studies follow all applicable laws and regulations.

A type of
allocation strategy in which participants are assigned to the
arms of a clinical trial by chance.

Not yet recruiting: The study has not started recruiting participants.

Recruiting: The study is currently recruiting participants.

Enrolling by invitation: The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate.

Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.

Suspended: The study has stopped early but may start again.

Terminated: The study has stopped early and will not start again. Participants are no longer being examined or treated.

Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Withdrawn: The study stopped early, before enrolling its first participant.

Unknown: A study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been last verified within the past 2 years.

The process of submitting and updating summary information about a clinical study and its
protocol, from its beginning to end, to a structured, public Web-based
study registry that is accessible to the public, such as ClinicalTrials.gov.

Countries that appeared under
listed location countries but were removed from the
study record by the sponsor or investigator.

A grouping of participants in a clinical study that is used for summarizing the data collected during the study. This grouping may be the same as or different from a study arm or group.

The person responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information. Usually the study sponsor or investigator.

A structured online system, such as the ClinicalTrials.gov results database, that provides the public with access to registration and summary results information for completed or terminated clinical studies. A study with results available on ClinicalTrials.gov is described as having the results "posted."

Note: The ClinicalTrials.gov results database became available in September 2008. Older studies are unlikely to have results available in the database.

Indicates that the sponsor or investigator submitted a
certification or
extension request.

The date on which summary results information was first available on ClinicalTrials.gov. There is typically a delay between the date the study sponsor or investigator first submits summary results information (the
results first submitted date) and the results first posted date.

The date on which the study sponsor or investigator first submits a
study record with summary results information. There is typically a delay between the results first submitted date and when summary results information becomes available on ClinicalTrials.gov (the
results first posted date).

The date on which the study sponsor or investigator first submits a
study record with summary results information that is consistent with National Library of Medicine (NLM)
quality control (QC) review criteria. The sponsor or investigator may need to revise and submit results information one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.

The date on which the National Library of Medicine provided
quality control (QC) review comments to the study sponsor or investigator. The sponsor or investigator must address major issues identified in the review comments. If there is a date listed for results returned after quality control review, but there is not a subsequent date listed for
results submitted to ClinicalTrials.gov, this means that the submission is pending changes by the sponsor or investigator.

The date on which the study sponsor or investigator first submitted summary results information or submitted changes to summary results information. Submissions with changes are typically in response to
quality control (QC) review comments from the National Library of Medicine (NLM). If there is a date listed for results submitted to ClinicalTrials.gov, but there is not a subsequent date listed for
results returned after quality control review, this means that the submission is pending review by NLM.

In a clinical study's
protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.

An
adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.

A type of
eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from
gender-based eligibility.

An
arm type in which a group of participants receives a procedure or device that appears to be the same as the actual procedure or device being studied but does not contain active processes or components.

A type of
intervention model describing a clinical trial in which all participants receive the same intervention/treatment.

In Advanced Search, the Sort studies by option is used to change the order of studies listed on the Search Results page. You can sort by Relevance or Newest First:

Relevance: Studies that best match your search terms appear higher in the search results list. This is the default display for all searches.

Newest First: Studies with the most recent First posted dates appear higher in the search results list.

The organization or person who initiates the study and who has authority and control over the study.

In the search feature, the State field is used to find clinical studies with locations in a specific state within the United States. If you choose United States in the
Country field, you can search for studies with locations in a specific state.

The written description of the statistical considerations and methods for analyzing the data collected in the
clinical study.

Indicates the current
recruitment status or the
expanded access status.

The date on which the last participant in a clinical study was examined or received an
intervention/treatment to collect final data for the
primary outcome measures,
secondary outcome measures, and
adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.

The investigative methods and strategies used in the clinical study.

Refers to the type of documents that the study sponsor or principal investigator may add to their
study record. These include a study
protocol,
statistical analysis plan, and
informed consent form.

Identifiers that are assigned to a clinical study by the study's
sponsor, funders, or others. They include unique identifiers from other trial
study registries and National Institutes of Health grant numbers. Note: ClinicalTrials.gov assigns a unique identification code to each clinical study registered on ClinicalTrials.gov. Also called the
NCT number, the format is "NCT" followed by an 8-digit number (for example, NCT00000419).

An entry on ClinicalTrials.gov that contains a summary of a clinical study's protocol information, including the
recruitment status; eligibility criteria; contact information; and, in some cases, summary results. Each study record is assigned a ClinicalTrials.gov identifier, or
NCT number.

A structured online system, such as ClinicalTrials.gov, that provides the public with access to summary information about ongoing and completed clinical studies.

The official title of a
protocol used to identify a clinical study or a short title written in language intended for the lay public.

The acronym or initials used to identify a clinical study (not all studies have one). For example, the title acronym for the Women's Health Initiative is "WHI."

An agency within the U.S. Department of Health and Human Services. The FDA is responsible for protecting the public health by making sure that human and veterinary drugs, vaccines and other biological products, medical devices, the Nation's food supply, cosmetics, dietary supplements, and products that give off radiation are safe, effective, and secure.

A type of
recruitment status. It identifies a study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been verified within the past 2 years. Studies with an unknown status are considered closed studies.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

This is a pilot study designed as a prospective, randomized controlled trial comparing arthroscopic Bankart repair and Remplissage with an open Latarjet coracoid transfer for the treatment of recurrent anterior glenohumeral instability with subcritical bone loss.

Presently, consensus guidelines for the surgical management of anterior glenohumeral instability are lacking. While there has been continual evolution in available arthroscopic instrumentation, this has not translated to improvements in patient outcomes. Isolated arthroscopic bankart repair is often associated with unacceptably high rates of failure, with a recent systematic review identifying continued recurrence rates of 14.2%. Improved recognition of bone defects and identification of critical defect sizes that contribute to recurrent instability and failed stabilization have lead to improvements in treatment algorithms. It has been widely accepted that glenoid defects exceeding 20% of anteroposterior (AP) width and humeral head defects exceeding 30% of the humeral head width contribute to recurrent instability. For defects of this magnitude, isolated arthroscopic Bankart repair is insufficient in restoring joint stability, and more extensive procedures are required. This can include adding a remplissage to the arthroscopic Bankart repair or open allograft reconstruction for humeral defects; or Latarjet coracoid transfer for glenoid defects.

However, often patients present with combined 'bipolar' bone loss, where individual defects are subcritical in size. There is increasing recognition that the presence of this combined bone loss may lead to increased rates of failure with an isolated arthroscopic bankart repair. Currently, accepted treatment options for bipolar bone loss include a combined arthroscopic Bankart repair and remplissage, or a Latarjet coracoid transfer. While there is supportive biomechanical data for each procedure, and limited case series in the literature, there remains a paucity of high-quality evidence to guide treatment for this complex clinical scenario. Consequently, we aim to perform a pilot study designed as a prospective, randomized controlled trial comparing arthroscopic Bankart repair and Remplissage with an open Latarjet coracoid transfer.

Patients randomized to the all-arthroscopic group (Bankart repair and remplissage) will undergo a standard arthroscopic anterior labral repair with a minimum of 3 suture anchors, followed by remplissage with 1 or 2 anchors, at the discretion of the treating surgeon.

Procedure: Bankart Repair plus Remplissage

Arthroscopic Bankart repair with a minimum of 3 anchors

1 or 2 anchor Remplissage subsequently performed with percutaneous anchor insertion in the base of the Hill-Sachs defect, and sutures passed in a horizontal mattress configuration 1 cm apart, tied in the subacromial space.

Active Comparator: Latarjet Coracoid Transfer

Patients randomized to the open Latarjet coracoid transfer will undergo a Latarjet coracoid transfer through a deltopectoral approach and horizontal split in the subscapularis at the superior 2/3, inferior 1/3 junction. The coracoid process will be oriented in the conventional manner, with the inferior surface against the glenoid vault, secured with two cannulated screws

Procedure: Latarjet coracoid transfer

Coracoid transfer performed via deltopectoral approach with horizontal subscapularis split. Graft placed in the conventional orientation, secured with 2 screws, ensuring the graft is not lateral to the glenoid rim.

Western Ontario Shoulder Instability (WOSI) questionnaire is a tool designed for self-assessment of shoulder function for patients with instability problems. Difference between study arm outcomes will be assessed using pre-op and post-op WOSI score as a covariate.

Subscale scores are added to determine the total score out of a possible 2100 points, with 2100, or 100%, representing the worst possible score.

Secondary Outcome Measures :

Pain numeric rating scale (NRS) [ Time Frame: 24 months ]

This tool is designed to evaluate pain. The Scale is from 0-100 to determine shoulder pain pre and post-operatively; 0=extreme pain, 100=no pain

Simple Shoulder Test (SST) [ Time Frame: 24 months ]

Simple Shoulder Test (SST) is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. The answers to these questions provides a standardized way of recording the function of a shoulder before and after treatment. Differences between study arm outcomes will be assessed using pre-op SST scores as a covariate

The ASES assessment (patient report section) is a region-specific questionnaire designed for self-assessment of aspects of pain and function. Difference between study arm outcomes will be assessed using pre-op ASES score as a covariate

Range of motion [ Time Frame: 24 months ]

Range of motion will be evaluated using a goniometer to calculate: forward flexion, abduction, external rotation and internal rotation

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.